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Background <p>Patient-reported experience measures are valuable instruments for assessing care quality in alignment with the Triple Aim framework. We sought to validate the PREM-PS questionnaire (Patient Reported Experience Measure – Prenatal Screening) by evaluating its psychometric properties (structural validity, internal consistency, and cross-cultural validity) for Canadian French-and English-speaking populations.</p> Methodology <p>This secondary analysis used data from a prospective, open-label, multicenter randomized trial in Quebec and British Columbia (2019–2023). Pregnant women aged 19+ were randomized 2:1 to receive either first-tier cell-free DNA (cfDNA) or traditional biochemical screening for chromosomal anomalies (T21, T18, T13). Participants completed the PREM-PS, a 10-item questionnaire on a 5-point Likert scale, at 22 weeks of pregnancy. Exploratory factor analysis, conducted separately for French and English questionnaires, used half the data to identify underlying factors. Confirmatory factor analysis of the remaining data evaluated structural validity. Internal consistency was assessed using Cronbach’s alpha, and cross-cultural validity through measurement invariance analyses. Mean scores were compared across arms using linear mixed models.</p> Results <p>Of 7815 enrolled pregnant women, 3398 completed the French questionnaire and 2875 the English version (80.3% response rate, 96.4% completion rate). Mean age was 32.11 years (SD = 4.01), with 65.1% identifying as White. Factor analyses retained seven items grouped into two latent factors interpreted as Communication and Professionalism. Standardized loadings from exploratory factor analysis ranged from 0.66–0.93 (French) and 0.69–0.96 (English), while standardized parameter estimates from the confirmatory factor analysis ranged from 0.67–0.98 (French) and 0.62–0.98 (English). Cronbach’s alpha exceeded 0.85 for both factors in French and 0.88 in English. No significant differences were observed between the two study arms for either Professionalism or Communication scores, indicating comparable patient-reported experiences regardless of screening method.</p> Conclusion <p>The PREM-PS demonstrates adequate validity for assessing patient-reported experiences of pregnant women undergoing prenatal screening in both Canadian French and English, with potential to guide improvements in prenatal care.</p> Trial registration <p>ClinicalTrials.gov, NCT03831256. Registered February 5<sup>th</sup>, 2019, <a href="https://clinicaltrials.gov/study/NCT03831256?term=NCT03831256%26rank=1">https://clinicaltrials.gov/study/NCT03831256?term=NCT03831256&amp;rank=1</a></p>

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Validation of PREM-PS, a patient-reported experience instrument, in a randomized controlled trial of pregnant women undergoing prenatal screening

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  • 发表日期：

    2026年3月7日

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  • Alix Dubeau,
  • Meryeme El Balqui,
  • Denis Talbot,
  • François Rousseau,
  • Sylvie Langlois,
  • Weihong Chen,
  • François Audibert,
  • Emmanuel Bujold,
  • Jean-Claude Forest,
  • Suélène Georgina Dofara,
  • France Légaré

摘要

Background

Patient-reported experience measures are valuable instruments for assessing care quality in alignment with the Triple Aim framework. We sought to validate the PREM-PS questionnaire (Patient Reported Experience Measure – Prenatal Screening) by evaluating its psychometric properties (structural validity, internal consistency, and cross-cultural validity) for Canadian French-and English-speaking populations.

Methodology

This secondary analysis used data from a prospective, open-label, multicenter randomized trial in Quebec and British Columbia (2019–2023). Pregnant women aged 19+ were randomized 2:1 to receive either first-tier cell-free DNA (cfDNA) or traditional biochemical screening for chromosomal anomalies (T21, T18, T13). Participants completed the PREM-PS, a 10-item questionnaire on a 5-point Likert scale, at 22 weeks of pregnancy. Exploratory factor analysis, conducted separately for French and English questionnaires, used half the data to identify underlying factors. Confirmatory factor analysis of the remaining data evaluated structural validity. Internal consistency was assessed using Cronbach’s alpha, and cross-cultural validity through measurement invariance analyses. Mean scores were compared across arms using linear mixed models.

Results

Of 7815 enrolled pregnant women, 3398 completed the French questionnaire and 2875 the English version (80.3% response rate, 96.4% completion rate). Mean age was 32.11 years (SD = 4.01), with 65.1% identifying as White. Factor analyses retained seven items grouped into two latent factors interpreted as Communication and Professionalism. Standardized loadings from exploratory factor analysis ranged from 0.66–0.93 (French) and 0.69–0.96 (English), while standardized parameter estimates from the confirmatory factor analysis ranged from 0.67–0.98 (French) and 0.62–0.98 (English). Cronbach’s alpha exceeded 0.85 for both factors in French and 0.88 in English. No significant differences were observed between the two study arms for either Professionalism or Communication scores, indicating comparable patient-reported experiences regardless of screening method.

Conclusion

The PREM-PS demonstrates adequate validity for assessing patient-reported experiences of pregnant women undergoing prenatal screening in both Canadian French and English, with potential to guide improvements in prenatal care.

Trial registration

ClinicalTrials.gov, NCT03831256. Registered February 5th, 2019, https://clinicaltrials.gov/study/NCT03831256?term=NCT03831256&rank=1